None listed
Conditions
Interventions
Drug : OKT and Placebo groups take prescribed medication orally , 3g each time, 3 times per day, each taken before or between meals for 8 weeks.
Sponsors
Sangji University Oriental Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female aged 19 to 59 years have a complaint of cold hypersensitivity on hands and feet 2. Subject must include at least one or more of the following symptoms below: • Subject has the symptoms of cold hands and feet in normal temperature which most individuals feel no cold • Subject has the symptoms of severe cold hands and feet in colder than normal temperature exposure • Even subject is on the return to a warmer environment, the symptoms of cold hands and feet is not completely disappeared 3. When subject's VAS(Visual Analogue Scale) of cold hypersensitivity on feet VAS) is 4 or more 4. When subject's both upper arms exposure to room temperature (24?±2), the thermal deviation between the foot (acupuncture point, LR3) with the thigh(acupuncture point, S32) may be higher than 2? 5. Ability to comply with all study-related procedures, medications, and evaluations 6. Ability to give informed consent
Exclusion criteria
Exclusion criteria: - Patients who are admission to calcium antagonists and beta-blockers as a treatment of cold hypersensitivity on hands and feet - Patients who are having one or more finger gangrene or ulceration - Patients who are diagnosed by hyperthyroidism or currently medicated to thyroid drugs - Patients who are diagnosed by Autoimmune disease or having a positive antinuclear antibody(ANA) test - Patients who are diagnosed by Carpal Tunnel Syndrome or having a positive Tinel's sign and Phalen's tests - Patients who are diagnosed with Cervical disc herniation - Patients who are diagnosed with diabetes - Drug that may affect to the cold hypersensitivity on hands and feet(ex. anticoagulants) - Moderate level of liver dysfunction(each of AST, ALT greater than 100 IU/L) or kidney dysfunction patient(creatine 2.0mg/dL) - Due to the behaviour disorder or depression or anxiety neurosis or schizophrenia or serious mental illness, do not cooperate with treatment and follow up - Diagnosed with moderate anemia and hematologic disorders (adult non-pregnant women hemoglobin level less than 7g/dL, hematocrit level less than 26%, white blood cell level greater than 11,000/mm3) - Systolic blood pressure 180mmHg or diastolic blood pressure is greater than 100 mmHg based on average value of at least 2 measurements - Suspected arrhythmia that showed up on electrocardiogram(ECG) or diagnosed by heart disease, such as, ischemic heart disease - Alcohol or drug abuse - Female patients who are pregnant (positive urin - human chorionic gonadotropin) or lactating or have the chances of pregnancy - Diagnosed with malignant tumors - Participated in other clinical trials - Refused to participate in this trial - Able to understand and speak Korean - Patients who are judged to be inappropriate for the clinical study by the researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS(Visual Analogue Scale) of cold hypersensitivity on feet | — |
Secondary
| Measure | Time frame |
|---|---|
| VAS(Visual Analogue Scale) of cold hypersensitivity on hand;Questionnaire of WHO Quality of Life Scale Abbreviated Version(WHOQOL-BREF);Temperatures of hand and feet (by check Thermometer);Cold stress test;Questionnaire of demonstration;Questionnaire of cold hypersensitivity | — |
Countries
Korea, Republic of
Contacts
Public ContactLee
Semyung University
Outcome results
None listed